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CTRI Number  CTRI/2024/09/073660 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   Effectiveness of two treatment technique to improve posture and shoulder joint function among college students with long standing neck pain  
Scientific Title of Study   Postural stabilization versus shoulder stabilization exercises for the management of chronic mechanical neck pain among medical student with rounded shoulder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tushar valecha 
Designation  BPT Undergraduate Student  
Affiliation  MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI SOLAN 
Address  Room number 510 Department of physiotherapy Maharishi Markandeshwar medical college and hospital Kumarhatti Solan

Solan
HIMACHAL PRADESH
173229
India 
Phone  7018231090  
Fax    
Email  tusharvalechax@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arushi Mishra 
Designation  Assistant professor  
Affiliation  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan 
Address  Room number 510 Department of physiotherapy Maharishi Markandeshwar medical college and hospital Kumarhatti Solan

Solan
HIMACHAL PRADESH
173229
India 
Phone  8219368147  
Fax    
Email  arushimishra799@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deeksha Sharma  
Designation  Assistant professor  
Affiliation  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan 
Address  Room number 510 Department of physiotherapy Maharishi Markandeshwar medical college and hospital Kumarhatti Solan

Solan
HIMACHAL PRADESH
173229
India 
Phone  8146966176  
Fax    
Email  deeksha0075sharma@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan, Himachal Pradesh ,India Pin code 173212 
 
Primary Sponsor  
Name  TUSHAR VALECHA 
Address  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan, Himachal Pradesh, India Pim code 173212 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
Arushi Mishra  Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrArushi Mishra  Maharishi Markandeshwar Medical college and hospital Kumarhatti,Solan  Maharishi Markandeshwar Medical college and hospital Physiotheraphy department Room number 510, Kumarhatti,Solan
Solan
HIMACHAL PRADESH 		 8219368147

arushimishra799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Maharishi Markandeshwar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic mechanical neck pain with rounded shoulder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Postural stabilization exercise along with conventional physiotherapy  Postural stabilization exercise is a group of exercises which include 1 Modified prone cobra with patient in prone position with a hold of 30 seconds 2 Seated bent rows exercise in sitting position 3 Scapular protraction with patient lying in prone position and 4 Prone to y to w on Swiss ball each exercise is performed 3 times a week with 3 sets with repetition of 10 conventional physiotherapy include exercise such as 1 Neck muscle contraction exercise using TheraBand in standing position 2 Doorway stretch in standing position with a hold of 30 seconds 3 Chin tuck with foam roller placed at nape of the neck with patient lying in supine position pectoralis stretch on foam roller with foam roller placed between scapular blades in supine position with a hold of 5 seconds each exercise is performed 3 times a week with 3 sets and 10 repetition  
Comparator Agent  Shoulder stabilization exercise along with conventional physiotherapy  Shoulder stabilization exercise is a group of exercise which include exercise such as Proprioceptive neuromuscular facilitation for shoulder joint in supine and standing position Push up exercise in prone position shoulder flexion and extension exercise in standing or sitting position and face pull exercise in sitting position each exercise is performed for 3 times a week for a total of 3 sets with 10 repetition Conventional physiotherapy include exercise such as neck muscle contraction exercise using TheraBand in standing position doorway stretch in standing position with a hold of 30 seconds chin tuck with foam roller where roller is placed at nape of the neck with patient lying in supine position pectoralis stretch on foam roller with foam roller placed between scapular blades in supine position with a hold of 5 seconds each exercise is performed 3 times a week with 3 sets and 10 repetition 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Medical students with chronic mechanical neck pain and rounded shoulder
Neck pain of more than or equal to 5 on numerical pain rating scale with duration of pain more than 3 months  
 
ExclusionCriteria 
Details  Any musculoskeletal condition such as radiating pain
Cardiopulmonary disorders associated with postural changes or any neurological condition any history of spinal fracture shoulder blade injury with cervical neck fracture and dermatological problems and uncooperative patient  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numeric pain rating scale (NPRS)
Neck disability index (NDI)
Shoulder pain and disability index (SPDAI) 		 Two time measurement(on day 1 and on day 21)  
 
Secondary Outcome  
Outcome  TimePoints 
Pectoralis Tightness Test  Two Time Measurement(on day 1 & on day 21) 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Chronic mechanical neck pain(CMNP) is a non-specific discomfort felt in the area of the cervicothoracic junction that is exacerbated by minor motions occurring over an extended period of time. CMNP symptoms ranges from basic aches and proceed to postural tiredness in the neck, shoulders, and arms, as well as persistent pain or discomfort in surrounding soft tissues. Students are at a higher risk of developing neck pain due to prolonged reading, writing and clinical practice, in addition to other factors that contribute to pain in the general population A study found that 54% of medical students at a American institution experienced regular neck pain Furthermore, medical students frequently use of gadgets increase the severity.  A total of 64 participants both male and female will be included in the study.  All the subjects will be divided into 2  groups , group 1 and group 2. Baseline assessment of patients will be done using outcome measures such as numerical pain rating scale , shoulder pain and disability assessment scale , neck disability scale  and pectoralis tightness test . Subjects in group 1 will receive  shoulder stabilization along with conventional physiotherapy and subjects in group 2 will receive postural stabilization exercises along with conventional physiotherapy 3 times a week for 3 weeks . 
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